FDA Medical Device Recalls (openFDA)
TAG Medical Corp.: Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101
- Recall number
- Z-0656-2010
- Recalling firm
- TAG Medical Corp.
- Product
- Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101
- Status
- Terminated
- Initiated
- 2009-12-04
- Posted
- 2010-01-19
- Terminated
- 2016-02-29
- Reason
- Device failed to deploy the distal loop
- Root cause
- Process change control
- Action
- Medicsense, the US Agent notified the sole distributor Tornier Inc., Edina, MN of the recall and requested notification to users requesting to discontinue and return product. Letter to customers dated December 4, 2009.
- Quantity
- 60 UNITS
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 09K1, 09J5, 09J6, 09K3, 09K4, & 09K5
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBH
- Firm FEI
- 1000272060
- Firm city
- Gaaton Naharia
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28